Events

Recall of STERRAD 100NX (Gas Plasma Steriliser)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-01242-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-11-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01242-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The manufacturer, asp has determined that welds could loosen on the frame of sterrad 100nx sterilizers manufactured between october 2012 and june 2013. these welds are used to secure support rails to the top tray assembly for added rigidity. the failure of the broken weld could potentially cause the chassis to deflect concaving downward. this failure does not impact the sterrad 100nx sterilizer components performance.
  • Action
    A JJM Field Service Engineer will install rivets and brackets to ensure the support rail brackets are firmly attached to the chassis to prevent possible separation.

Device

STERRAD 100NX (Gas Plasma Steriliser)
  • Model / Serial
    STERRAD 100NX (Gas Plasma Steriliser)Product Number: 10104-002Affected Serial Numbers: 1042130065, 1042130028, 1042130024, 1042130067, 1042130002, 1042130063, 1042130064ARTG Number: 123603
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd